Clinical Project Manager/ Sr Clinical Project Manager - Ophthalmology Specific (Home-Based In Europe Or US)

Iqvia Holdings Inc Durham , NC 27701

Posted 2 months ago

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

This is an important and high-profile role within IQVIA to become a part of our passionate ophthalmology team. In the Clinical Project Manager / Sr Clinical Project Manager role you will drive the delivery of our ophthalmology phase II and III clinical studies and help to bring new therapies to market faster to ultimately improve patients' lives. This role will maximize your strong vendor management skills and your ability to influence and liaise with multiple leaders across IQVIA functions, such as data management, clinical monitoring, medical monitoring and safety. You will have strong budget and time management skills and will be comfortable acting as the accountable point of contact for your customers.

As a Clinical Project Manager / Sr Clinical Project Manager you will manage cross functional teams across our global organization. You will be supported by domain experts in every function and enabled by best-in-class technology, strong ophthalmology expertise via our Centre of Excellence and data analytics. Your key collaborators will be the Clinical Lead for site management, the Project Management Analyst for project coordination, tracking and financial analysis and the Site Activation Manager for start-up activities. IQVIA's size and global footprint will present you with the breadth of opportunities necessary to develop your career.

As a member of the Ophthalmology Centre of Excellence within our Project Leadership organization, you will be responsible for delivery of global and/or regional studies and / or critical process and vendor management in a variety of ophthalmic indications including both front and back of the eye studies. Our team is growing quickly, and candidates with experience in the following areas can expect to have a strong impact:

  • AMD

  • DME

  • Rare inherited retinal disease such as retinitis pigmentosa

  • Dry eye

  • Glaucoma

  • Conjunctivitis

You will need to be comfortable collaborating and communicating with a variety of stakeholders and demonstrate flexible and creative leadership. Global experience and a biopharmaceutical, CRO or related vendor (Ophthalmic Imaging, BCVA certification, Labs, eCOA, etc) is ideal.

While project assignments vary, your typical responsibilities might include:

  • Serving as the primary project contact with the client

  • Leading and managing cross-functional project teams

  • Leading problem-solving including management of risk and issue resolution

  • Developing or reviewing study management plans

  • Managing team resource assignments and accountability

  • Study finance and budget management

  • Project status reporting and surveillance for risk

  • Monitoring team performance against contract and client expectations and according to key performance metrics

  • Oversight of database management

  • Ensuring compliance with study tools, training materials and standard processes, policies and procedures.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Clinical Trial Manager (Sr Clinical Lead) (Sponsor Specific Model)

Iqvia Holdings Inc

Posted 1 week ago

VIEW JOBS 6/26/2020 12:00:00 AM 2020-09-24T00:00 IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. As an award winning CRO, we're offering a clear opportunity to Clinical Leads already working in a Clinical Lead, Clinical Trials Manager or Clinical Operations Manager role. Using our innovative and cutting-edge in-house technology you'll be key to improving the efficiency of our global trials. You'll get things done sooner and you'll get them done more efficiently. This focus on getting our customers' products to market as quickly as possible is critical - for the benefit of both the customer and the patient. As a result, this is an essential role within our business, and it's structured to give our Clinical Leads the authority and support to ensure outstanding results. Working closely and in tandem with the Project Leader, you'll be the individual responsible for meeting the overall clinical delivery requirements. While projects vary, your typical responsibilities might include: * Managing the clinical operational aspects of projects, risk management plans, and representing clinical delivery with the customer * Working closely with the project leader and lead clinical analyst (LCA) on clinical issue resolution, while remaining ultimately accountable for your clinical team's results • Delivering the project according to the quality management plan • Driving the development and performance of the clinical team, you should also have a good knowledge of the Good Clinical Practice guidelines. You will also need to be comfortable working closely with customers and senior colleagues across the business, mentoring junior colleagues and where appropriate, influencing decision making at all levels. PURPOSE: Clinical Leadership is focused on the delivery and quality of the contracted clinical services within a project to achieve customer satisfaction. Focus is on leveraging clinical operations and therapeutic expertise along with the diverse IQVIA solutions to drive operational excellence particularly in respect to subject/patient recruitment and on-time high quality data collection. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project's overall objectives to the Sponsor's satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies and practices. We are currently seeking talented individuals with expertise in the following areas: Cardiovascular, Renal, Metabolic, Oncology, Gastrointestinal, Central Nervous System, Neuroscience, Internal Medicine, and more. These roles are full time home-based and require approximately 15% travel annually. RESPONSIBILITIES: * Accountable for ensuring the "right subjects" and "right data" to meet our contractual requirements. * Participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country/region studies, in partnership with business development and senior project leader as needed. * Develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy plan, etc. to be incorporated into the integrated study management plan/project management plan. * Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives. * Ensure all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed. * Ensure all processes and tools are available to maximize clinical team's ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment. Throughout the study these strategies and materials should be kept under constant review and updated in response to progress on the study to ensure clear understanding by all parties (internal and external) of expectations throughout the recruitment period; and inspire customer confidence in a clear and enforced action plan and thereby ensure successful delivery to customer satisfaction. * Monitor clinical progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required. * Deliver the project/program according to the quality management plan. Guide CRA's and advise on critical specific study issues. * Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. * Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies. Partner with functional leaders in problem solving and resolution efforts. * Achieve project quality by identifying quality risks and issues, responding to issues which impact the clinical delivery, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans. * Serve as clinical project contact with customer where applicable and agreed with the project leader. * Drive for high performance and efficiency of the clinical team to support financial success of the project. * Support the project leader in ensuring the financial success of the project. * Identify changes in scope and support project leader in completion of the change control process. * Identify and communicate lessons learned and implement best practices to promote continuous improvement. * Adopt corporate initiatives and changes and serve as a change advocate when necessary. * Provide input to line managers of their project team members' performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Broad protocol knowledge; therapeutic knowledge * Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates * Ability to understand customer needs and appropriately influence decision making * Good understanding of other company functions and their inter-relationship to achieve project delivery * Knowledge of Project management practices and terminology * Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof * Good understanding of project financials * Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently * Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively * Excellent communication and presentation skills, including good command of English language * Demonstrated proficiency in using systems and technology to achieve work objectives * Proven ability at analyzing data and information to derive conclusions and drive sound decision making * Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it * Excellent customer service skills and demonstrated ability to understand customer needs and appropriately influence decision making * Strong software and computer skills, including MS Office applications * Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving * Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in a health care or other scientific discipline with 7 years clinical research/monitoring experience; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * May require occasional travel (average of 15% annually) * Home-based Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation. Iqvia Holdings Inc Durham NC

Clinical Project Manager/ Sr Clinical Project Manager - Ophthalmology Specific (Home-Based In Europe Or US)

Iqvia Holdings Inc